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Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients.

ABSTRACT: Previous research indicates that preventive intervention is likely to benefit patients "at risk" of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive-behavioural case management and antidepressant medication. A secondary aim is to test biological and psychological variables that moderate and mediate response to this sequential treatment strategy.This is a sequential multiple assignment randomised trial (SMART) consisting of three steps: Step 1: SPS (1.5 months); Step 2: SPS vs Cognitive Behavioural Case Management (4.5 months); Step 3: Cognitive Behavioural Case Management?+?Antidepressant Medication vs Cognitive Behavioural Case Management?+?Placebo (6 months). The intervention is of 12 months duration in total and participants will be followed up at 18 months and 24 months post baseline.This paper reports on the rationale and protocol of the Staged Treatment in Early Psychosis (STEP) study. With a large sample of 500 UHR participants this study will investigate the most effective type and sequence of treatments for improving functioning and reducing the risk of developing psychotic disorder in this clinical population.

SUBMITTER: Nelson B

PROVIDER: S-EPMC6054879 | biostudies-other | 2018 Jun

REPOSITORIES: biostudies-other

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Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients.

Nelson Barnaby B Amminger G Paul GP Yuen Hok Pan HP Wallis Nicky N J Kerr Melissa M Dixon Lisa L Carter Cameron C Loewy Rachel R Niendam Tara A TA Shumway Martha M Morris Sarah S Blasioli Julie J McGorry Patrick D PD

Early intervention in psychiatry 20170718 3

<h4>Aim</h4>Previous research indicates that preventive intervention is likely to benefit patients "at risk" of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive-behavioural case managemen ...[more]

PMID: 28719151

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Project description:ImportanceClinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis.ObjectiveTo determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis.Design, setting, and participantsThe Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited.InterventionsStep 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (CBCM) vs SPS; and step 3: 26 weeks of CBCM with fluoxetine vs CBCM with placebo with an embedded fast-fail option of ω-3 fatty acids or low-dose antipsychotic medication. Individuals who did not remit progressed through these steps; those who remitted received SPS or monitoring for up to 12 months.Main outcomes and measuresGlobal Functioning: Social and Role scales (primary outcome), Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Montgomery-Åsberg Depression Rating Scale, quality of life, transition to psychosis, and remission and relapse rates.ResultsThe sample comprised 342 participants (198 female; mean [SD] age, 17.7 [3.1] years). Remission rates, reflecting sustained symptomatic and functional improvement, were 8.5%, 10.3%, and 11.4% at steps 1, 2, and 3, respectively. A total of 27.2% met remission criteria at any step. Relapse rates among those who remitted did not significantly differ between SPS and monitoring (step 1: 65.1% vs 58.3%; step 2: 37.7% vs 47.5%). There was no significant difference in functioning, symptoms, and transition rates between SPS and CBCM and between CBCM with fluoxetine and CBCM with placebo. Twelve-month transition rates to psychosis were 13.5% (entire sample), 3.3% (those who ever remitted), and 17.4% (those with no remission).Conclusions and relevanceIn this sequential multiple assignment randomized trial, transition rates to psychosis were moderate, and remission rates were lower than expected, partly reflecting the ambitious criteria set and challenges with real-world treatment fidelity and adherence. While all groups showed mild to moderate functional and symptomatic improvement, this was typically short of remission. While further adaptive trials that address these challenges are needed, findings confirm substantial and sustained morbidity and reveal relatively poor responsiveness to existing treatments.Trial registrationClinicalTrials.gov Identifier: NCT02751632.

Project description:IntroductionOver 40% of US adults meet criteria for obesity, a major risk factor for chronic disease. Obesity disproportionately impacts populations that have been historically marginalised (eg, low socioeconomic status, rural, some racial/ethnic minority groups). Evidence-based interventions (EBIs) for weight management exist but reach less than 3% of eligible individuals. The aims of this pilot randomised controlled trial are to evaluate feasibility and acceptability of dissemination strategies designed to increase reach of EBIs for weight management.Methods and analysisThis study is a two-phase, Sequential Multiple Assignment Randomized Trial, conducted with 200 Medicaid patients. In phase 1, patients will be individually randomised to single text message (TM1) or multiple text messages (TM+). Phase 2 is based on treatment response. Patients who enrol in the EBI within 12 weeks of exposure to phase 1 (ie, responders) receive no further interventions. Patients in TM1 who do not enrol in the EBI within 12 weeks of exposure (ie, TM1 non-responders) will be randomised to either TM1-Continued (ie, no further TM) or TM1 & MAPS (ie, no further TM, up to 2 Motivation And Problem Solving (MAPS) navigation calls) over the next 12 weeks. Patients in TM+ who do not enrol in the EBI (ie, TM+ non-responders) will be randomised to either TM+Continued (ie, monthly text messages) or TM+ & MAPS (ie, monthly text messages, plus up to 2 MAPS calls) over the next 12 weeks. Descriptive statistics will be used to characterise feasibility (eg, proportion of patients eligible, contacted and enrolled in the trial) and acceptability (eg, participant opt-out, participant engagement with dissemination strategies, EBI reach (ie, the proportion of participants who enrol in EBI), adherence, effectiveness).Ethics and disseminationStudy protocol was approved by the University of Utah Institutional Review Board (#00139694). Results will be disseminated through study partners and peer-reviewed publications.Trial registration numberclinicaltrials.gov; NCT05666323.

Project description:BACKGROUND:In the past two decades, the massive scale-up of long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS) has led to significant reductions in malaria mortality and morbidity. Nonetheless, the malaria burden remains high, and a dozen countries in Africa show a trend of increasing malaria incidence over the past several years. This underscores the need to improve the effectiveness of interventions by optimizing first-line intervention tools and integrating newly approved products into control programs. Because transmission settings and vector ecologies vary from place to place, malaria interventions should be adapted and readapted over time in response to evolving malaria risks. An adaptive approach based on local malaria epidemiology and vector ecology may lead to significant reductions in malaria incidence and transmission risk. METHODS/DESIGN:This study will use a longitudinal block-cluster sequential multiple assignment randomized trial (SMART) design with longitudinal outcome measures for a period of 3?years to develop an adaptive intervention for malaria control in western Kenya, the first adaptive trial for malaria control. The primary outcome is clinical malaria incidence rate. This will be a two-stage trial with 36 clusters for the initial trial. At the beginning of stage 1, all clusters will be randomized with equal probability to either LLIN, piperonyl butoxide-treated LLIN (PBO Nets), or LLIN + IRS by block randomization based on their respective malaria risks. Intervention effectiveness will be evaluated with 12?months of follow-up monitoring. At the end of the 12-month follow-up, clusters will be assessed for "response" versus "non-response" to PBO Nets or LLIN + IRS based on the change in clinical malaria incidence rate and a pre-defined threshold value of cost-effectiveness set by the Ministry of Health. At the beginning of stage 2, if an intervention was effective in stage 1, then the intervention will be continued. Non-responders to stage 1 PBO Net treatment will be randomized equally to either PBO Nets + LSM (larval source management) or an intervention determined by an enhanced reinforcement learning method. Similarly, non-responders to stage 1 LLIN + IRS treatment will be randomized equally to either LLIN + IRS + LSM or PBO Nets + IRS. There will be an 18-month evaluation follow-up period for stage 2 interventions. We will monitor indoor and outdoor vector abundance using light traps. Clinical malaria will be monitored through active case surveillance. Cost-effectiveness of the interventions will be assessed using Q-learning. DISCUSSION:This novel adaptive intervention strategy will optimize existing malaria vector control tools while allowing for the integration of new control products and approaches in the future to find the most cost-effective malaria control strategies in different settings. Given the urgent global need for optimization of malaria control tools, this study can have far-reaching implications for malaria control and elimination. TRIAL REGISTRATION:US National Institutes of Health, study ID NCT04182126 . Registered on 26 November 2019.

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Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients.

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Staged Treatment in Early Psychosis: A sequential multiple assignment randomised trial of interventions for ultra high risk of psychosis patients.

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